Savella
These highlights do not include all the information needed to use Savella safely and effectively. See full prescribing information for Savella. Savella® (milnacipran HCl) TabletsInitial U.S. Approval: 2009
Approved
Approval ID
d4e56a10-3b29-4270-ab42-60dc74049cc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
milnacipran hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6024
Application NumberNDA022256
Product Classification
M
Marketing Category
C73594
G
Generic Name
milnacipran hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2011
FDA Product Classification
INGREDIENTS (11)
milnacipran hydrochlorideActive
Quantity: 100 mg in 1 1
Code: RNZ43O5WW5
Classification: ACTIB
dibasic calcium phosphate dihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
carboxymethylcellulose calciumInactive
Code: UTY7PDF93L
Classification: IACT
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
milnacipran hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6043
Application NumberNDA022256
Product Classification
M
Marketing Category
C73594
G
Generic Name
milnacipran hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2011
FDA Product Classification
INGREDIENTS (13)
milnacipran hydrochlorideActive
Quantity: 50 mg in 1 1
Code: RNZ43O5WW5
Classification: ACTIB
dibasic calcium phosphate dihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
carboxymethylcellulose calciumInactive
Code: UTY7PDF93L
Classification: IACT
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C Yellow No. 5Inactive
Code: I753WB2F1M
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT